Anterior Temporal Epilepsy Neuropsychological Assessment of Faces
ATENA-F
Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched. Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJuly 24, 2019
July 1, 2019
4.1 years
August 31, 2016
July 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
day 0
Secondary Outcomes (2)
Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
day 0 and after 12 to 18 months
Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
day 0 and after 24 to 30 months
Study Arms (2)
Epilepsy
OTHERPatients do face specific tests during conventional pre-lobectomy intercritical assessment hospitalization (inclusion, day 0) and after 6 and 18 months from anterior temporal lobectomy
Control
OTHERControl individuals do face specific tests during inclusion visit (day 0) and after X months (X = time from day 0 and lobectomy of matched patient + 6 months)
Interventions
In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment
Eligibility Criteria
You may qualify if:
- ALL:
- Informed consent
- Affiliation to social security
- Preliminary medical examination
- PATIENTS WITH EPILEPSY:
- Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
- Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
- Nonverbal IQ ≥ 70 (WAIS-IV)
- At least 6 successful VOSP tests (perception test)
You may not qualify if:
- ALL:
- persons under legal protection or incapable to consent
- Persons deprived of liberty by juridical or administrative decision
- PATIENTS WITH EPILEPSY:
- \- Sever visual disorders of neurological or ophthalmological origin
- CONTROL INDIVIDUALS:
- Psychiatric or neurological disorders
- Important ophthalmological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Neurologie, Hôpital Central, CHU de Nancy
Nancy, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis Maillard
Service de Neurologie, Hôpital Central, CHU de Nancy, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 5, 2016
Study Start
August 1, 2013
Primary Completion
September 1, 2017
Study Completion
March 1, 2020
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share